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RECRUITING
NCT05394103
PHASE1/PHASE2

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Sponsor: Qurient Co., Ltd.

View on ClinicalTrials.gov

Summary

Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab

Official title: A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901Administered Via Intravenous Infusion as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Selected Advanced Solid Tumors With Cohort Expansions at the Recommended Phase 2 Dose

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2022-08-30

Completion Date

2026-08-30

Last Updated

2025-08-17

Healthy Volunteers

No

Interventions

DRUG

Q901

The study drug Q901 will be administered by IV infusion over a 30-minute period using a QW dosing schedule for 4 weeks, followed by a Q2W interval dosing schedule thereafter

DRUG

KEYTRUDA® (pembrolizumab)

KEYTRUDA® (pembrolizumab) will be administered Q6W

Locations (11)

Mayo Clinic

Phoenix, Arizona, United States

University of Southern California

Los Angeles, California, United States

Mayo Clinic

Jacksonville, Florida, United States

Northwestern University

Chicago, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

Atlantic Health System Hospital

Morristown, New Jersey, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

National Cancer Center

Goyang-si, South Korea

CHA University Bundang Medical Center

Seongnam-si, South Korea

Asan Medical Center

Seoul, South Korea

Severance Hospital

Seoul, South Korea